Effective understanding and use of the principles of information capture, storage, searching and retrieval.

Effective use of appropriate IT systems and programs.

Scientific knowledge

Ability to understand in detail clinical, biomedical and scientific reports about pharmaceutical products at a level to allow appropriate capture, review and processing of safety data.

Analytical skills

Ability to analyse and appraise safety data as part of the ongoing benefit-risk assessment of the companys products.

Ability to make informed decisions after finding the relevant facts.

Communication skills

Ability to communicate information effectively and clearly in written form to allow sharing of safety data within the company and to regulatory bodies as required.

Understanding the wider context

Knowledge of the business and of the pharmaceutical industry.

Understanding of the external environment: the NHS, Government policy, regulatory requirements.

Understanding of relevant legal and related issues

European and Global PV Regulations

Medicines Act and Statutory Instruments.

Data Protection legislation.

Copyright.

Ethics

Understanding of, and compliance with, company policies, legal requirements, the European Good Vigilance Practice Modules, ABPI Pharmacovigilance Expert Network guidance and other industry guidelines that are relevant to pharmacovigilance.

Application of sound professional judgement to ethical issues.

Workload Management

Ability to prioritise, plan and organise work with the appropriate sense of urgency based on regulatory requirements and business needs.

Personal skills

Team management and leadership skills (for team leaders and managers).

Strategic planning (especially for managers).

Interpersonal skills.

Understanding of the needs and priorities of regulatory bodies.

Use of effective questioning to accurately record safety data.

Ability to actively listen.

Teamwork.

Courteous manner and consideration of others' views.

Proactivity

Informing management of important issues as they arise which require their attention.

Ensuring all company employees and contractors are appropriately trained to capture safety data.

Actively increasing awareness of Pharmacovigilance requirements to colleagues and third parties in appropriate ways.

Accountability

Compliance with regulatory requirements.

Compliance with standard operating procedures and company policies.

Continuous development

Developing and improving knowledge and skills.

Keeping abreast of developments in regulatory requirements.

Developing the role in line with regulatory requirements and the company's needs.Identifying and implementing improvements in ways of working - for self and for team/department.